With rumors of a possible renewed push for Congressional legislation, IAMERS president Diana Upton and general counsel Robert Kerwin attended the AAMI Annual Meeting during the first week of June 2018. Their attendance is  part of IAMERS’ efforts to reduce the fear-mongering and  to get out the message of independent servicers for safe patient oriented servicing.

It was clear from the positive reactions of ISOs and HTM professionals to Mr. Kerwin’s remarks on behalf of IAMERS that many were disappointed with the efforts of some representing the manufacturing community to downplay the FDA report which found there to be no need for further regulation and which characterized third party servicing as critical to the healthcare ecosystem.   Responding to the  enthusiastic support of many in the AAMI meeting, he spoke 3 times regarding the FDA report on 3rd party service and what comes next. “Unfortunately we still hear that the manufacturers and their trade associations are pressing Congressional leaders to pass legislation regulating servicing and seeming  to be characterizing the FDA’s conclusions as a ‘blindspot’. We do not think that the FDA report evidenced a blindspot. To the contrary, we feel the 27 page report  was a careful analysis of the empirical evidence that there is not a safety problem as suggested by some. We think this should be a time for collaboration not polarization as ISOs contribute successfully to  much needed multi-vendor program.”   Hospital personnel and clinical engineers embraced his comments and statements of President Upton  as many have the same access challenges that IAMERS servicers have.  Pictured here with Katelyn Bittleman of FDA (a principal contributor to the FDA report)  and former ACCE president Steve Grimes.  Also with Crothall Compliance Officer Sheila O’Donnell and Pat Fitzgerald, Executive Vice President  and General Manager of Richardson Electric  at the DOTmed breakfast symposium held at AAMI.

Medical device recalls reach historic levels in 2018 with software as leading cause

Medical device recalls reached record highs in the first three months of 2018 thanks to software complications that are likely to continue with the proliferation of high-tech devices.

Read more here.

Congress delays medical device tax for two years

WASHINGTON — Almost no one got everything they wanted out of the Monday deal to reopen the government — except perhaps medical device companies, who managed to fend off an industry-wide excise tax before the first payments were due.   The stopgap spending deal that was signed by President Trump on Monday included a two-year delay of the 2.3 percent tax, which was originally included in the Affordable Care Act to help pay for the law’s health insurance subsidies.

Read more here.

Nationwide hosts IAMERS forum on QMS in advance of FDA report

Shortly before the summer congressional recess, the U.S. Senate passed a bipartisan bill to reauthorize the FDA user fee programs. The Senate User Fee bill followed the House bill and was approved 94-1. President Trump’s spokesperson has announced that the president will sign the bill.

See the full story at DOTmed by clicking here.


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